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Document C2004/300/63

Case C-431/04: Reference for a preliminary ruling by the Bundesgerichtshof by decision of that court of 29 June 2004 in the case of Massachusetts Institute of Technology

OJ C 300, 4.12.2004, p. 33–33 (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)

4.12.2004   

EN

Official Journal of the European Union

C 300/33

Reference for a preliminary ruling by the Bundesgerichtshof by decision of that court of 29 June 2004 in the case of Massachusetts Institute of Technology

(Case C-431/04)

(2004/C 300/63)

Reference has been made to the Court of Justice of the European Communities by decision of the Bundesgerichtshof (Federal Court of Justice) (Germany) of 29 June 2004 received at the Court Registry on 7 October 2004, for a preliminary ruling in the case of Massachusetts Institute of Technology on the following questions:

1.

Does the term ‘combination of active ingredients of a medicinal product’ within the meaning of Article 1(b) of Council Regulation 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (1) mean that the components of the combination must all be active ingredients with a therapeutic effect?

2.

Is there a ‘combination of active ingredients of a medicinal product’ also where a combination of substances comprising two components of which one component is a known substance with a therapeutic effect for a specific indication and the other component renders possible a pharmaceutical form of the medicinal product that brings about a changed efficacy of the medicinal product for this indication (in-vivo implantation with controlled release of the active ingredient to avoid toxic effects)?

(1)  OJ L 182, p. 1.

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